To the Editor We read with great interest the recent review of a small body of literature in JAMA Internal Medicine by Chatterjee et al.1
The implication by Chatterjee et al that somehow the US Food and Drug Administration (FDA) was lax in their approval of 510(k) class II status for the Lariat snare device (SentreHeart Inc) is perplexing. It is not unusual for device manufacturers to obtain marketing authorization for one use and then seek additional indications for a different use based on clinical need. Clinical scenarios often force physicians to make choices using clinical tools based on medical necessity. Those of us who have seen devastating bleeding complications from oral anticoagulation or strokes from failed anticoagulation strategies have chosen to close the left atrial appendage (LAA) with a device that is capable of doing the job with a high rate of complete closure.2 Many patients we have ligated with a Lariat had no choice other than open heart surgery or to stop their anticoagulation, which would leave them vulnerable to an atrial fibrillation (AF)-related stroke. Most cases where the Lariat is used off-label are “compassionate” cases that have no other FDA-approved alternative.
Nagaraj H, Wilber D, Lakkireddy DR. The Lariat for Left Atrial Appendage Closure: Rehash of Known Literature or a True Analysis?. JAMA Intern Med. 2015;175(11):1867-1868. doi:10.1001/jamainternmed.2015.5386